Clinical Trial

Evaluation of the Safety, Feasibility, and Early Clinical Outcomes of Patient-Specific Bone Defect Implants Fabricated From Titanium Alloy (Ti-6Al-4V) Using 3D Printing Technology

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Summary
The goal of this clinical trial is to evaluate the safety and feasibility of patient-specific bone defect implants fabricated from Ti-6Al-4V using 3D printing technology and to assess early clinical outcomes within the first 12 months following implantation of these customized devices. The main question it aims to answer is: "In patients with bone defects requiring surgical reconstruction, are patient-specific bone defect implants fabricated from titanium alloy (Ti-6Al-4V) using 3D printing technology - designed and produced at VinUni, safe and feasible for clinical use, and do they result in favorable early clinical outcomes within the first 12 months following implantation?"
Trial Details
NCT Number NCT07540156
Lead Sponsor VinUniversity
Collaborators: Vinmec Healthcare System
Conditions Bone Loss, Bone Defects
Enrollment 10 participants
Start Date 2026-04-01
Primary Completion 2027-06-30 (estimated)
Study Completion 2028-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-04-20